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FDA Accepts Pfizer's (PFE) sBLA Filing for Pneumococcal Jab
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Pfizer (PFE - Free Report) announced that the FDA accepted its supplemental biologics license application (sBLA) seeking label expansion for the use of its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) in infants and children aged six weeks through 17 years of age.
The sBLA has been granted priority review by the FDA. A filing designated as a priority review reduces the review period by four months. Management expects a decision on the sBLA by the end of this April.
The sBLA seeks approval for 20vPnC for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes – 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The sBLA also seeks to prevent of otitis media caused by Streptococcus pneumoniae serotypes – 4, 6B, 9V, 14, 18C, 19F, and 23F – in infants and children aged six weeks through 5 years. A similar filing was also submitted by Pfizer in the European Union last November.
If the sBLA is approved, the Pfizer vaccine will provide the broadest serotype coverage of any pneumococcal conjugate vaccine in the under-18 age group.
The sBLA is supported by data from late-stage and mid-stage clinical programs, which evaluated 20vPnC in pediatric patients. Data from the programs exhibited the safety, tolerability and immunogenicity of 20vPnC, which demonstrated the potential to help protect against more of the clinically significant remaining burden of disease.
Pfizer’s pneumococcal 20-valent conjugate vaccine is being marketed under the trade name Prevnar-20 and has been approved by the FDA for adults aged 18 years and older since June 2021. In the EU, the vaccine was approved for adults last February and is being marketed under brand name Apexxnar.
Shares of Pfizer have lost 9.5% in the year against the industry’s 15.3% rise.
Image Source: Zacks Investment Research
A pneumococcal infection is caused by the bacterium Streptococcus pneumoniae. While there are more than 100 different types of S. pneumoniae serotypes, only a few of these are responsible for the majority of the pneumococcal infections.
If the sNDA is approved, Prevnar-20 will provide stiff competition to Merck (MRK - Free Report) which markets Vaxneuvance, its own pneumococcal 15-valent conjugate vaccine which contains 15 Streptococcus pneumoniae serotypes.
Merck’s Vaxneuvance is already approved by the FDA for use in individuals aged six weeks and older. While the FDA initially approved Merck’s vaccine for use in adults in July 2021, it received label expansion for use in infants and adolescents in June 2022. Merck’s Vaxneuvance is also approved for similar use in the European Union in individuals aged six weeks and older.
Apart from Prevnar-20, Pfizer also markets another pneumococcal vaccine, Prevnar 13, which contains 13 Streptococcuspneumoniae serotypes and is approved for use in individuals aged six weeks and older. In the first nine months of 2022, Pfizer recorded $4.6 billion from combined sales of Prevnar 13 and Prevnar 20.
In the past 30 days, estimates for Novo Nordisk’s 2022 earnings per share have risen from $3.25 to $3.37. During the same period, the earnings estimates per share for 2023 have risen from $4.00 to $4.18. Shares of Novo Nordisk have risen 36.2% in the past year.
Earnings of Novo Nordisk beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 3.09%, on average. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 2.38%.
In the past 30 days, estimates for Sanofi’s 2022 earnings per share have risen from $4.23 to $4.29. During the same period, the earnings estimates per share for 2023 have risen from $4.25 to $4.34. Shares of Sanofi have declined 6.5% in the past year.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.50%, on average. In the last reported quarter, Sanofi’s earnings beat estimates by 9.85%.
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FDA Accepts Pfizer's (PFE) sBLA Filing for Pneumococcal Jab
Pfizer (PFE - Free Report) announced that the FDA accepted its supplemental biologics license application (sBLA) seeking label expansion for the use of its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) in infants and children aged six weeks through 17 years of age.
The sBLA has been granted priority review by the FDA. A filing designated as a priority review reduces the review period by four months. Management expects a decision on the sBLA by the end of this April.
The sBLA seeks approval for 20vPnC for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes – 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The sBLA also seeks to prevent of otitis media caused by Streptococcus pneumoniae serotypes – 4, 6B, 9V, 14, 18C, 19F, and 23F – in infants and children aged six weeks through 5 years. A similar filing was also submitted by Pfizer in the European Union last November.
If the sBLA is approved, the Pfizer vaccine will provide the broadest serotype coverage of any pneumococcal conjugate vaccine in the under-18 age group.
The sBLA is supported by data from late-stage and mid-stage clinical programs, which evaluated 20vPnC in pediatric patients. Data from the programs exhibited the safety, tolerability and immunogenicity of 20vPnC, which demonstrated the potential to help protect against more of the clinically significant remaining burden of disease.
Pfizer’s pneumococcal 20-valent conjugate vaccine is being marketed under the trade name Prevnar-20 and has been approved by the FDA for adults aged 18 years and older since June 2021. In the EU, the vaccine was approved for adults last February and is being marketed under brand name Apexxnar.
Shares of Pfizer have lost 9.5% in the year against the industry’s 15.3% rise.
Image Source: Zacks Investment Research
A pneumococcal infection is caused by the bacterium Streptococcus pneumoniae. While there are more than 100 different types of S. pneumoniae serotypes, only a few of these are responsible for the majority of the pneumococcal infections.
If the sNDA is approved, Prevnar-20 will provide stiff competition to Merck (MRK - Free Report) which markets Vaxneuvance, its own pneumococcal 15-valent conjugate vaccine which contains 15 Streptococcus pneumoniae serotypes.
Merck’s Vaxneuvance is already approved by the FDA for use in individuals aged six weeks and older. While the FDA initially approved Merck’s vaccine for use in adults in July 2021, it received label expansion for use in infants and adolescents in June 2022. Merck’s Vaxneuvance is also approved for similar use in the European Union in individuals aged six weeks and older.
Apart from Prevnar-20, Pfizer also markets another pneumococcal vaccine, Prevnar 13, which contains 13 Streptococcuspneumoniae serotypes and is approved for use in individuals aged six weeks and older. In the first nine months of 2022, Pfizer recorded $4.6 billion from combined sales of Prevnar 13 and Prevnar 20.
Pfizer Inc. Price
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Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap stocks in the overall healthcare sector include Novo Nordisk (NVO - Free Report) and Sanofi (SNY - Free Report) . While Novo Nordisk sports a Zacks Rank #1 at present, Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Novo Nordisk’s 2022 earnings per share have risen from $3.25 to $3.37. During the same period, the earnings estimates per share for 2023 have risen from $4.00 to $4.18. Shares of Novo Nordisk have risen 36.2% in the past year.
Earnings of Novo Nordisk beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 3.09%, on average. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 2.38%.
In the past 30 days, estimates for Sanofi’s 2022 earnings per share have risen from $4.23 to $4.29. During the same period, the earnings estimates per share for 2023 have risen from $4.25 to $4.34. Shares of Sanofi have declined 6.5% in the past year.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.50%, on average. In the last reported quarter, Sanofi’s earnings beat estimates by 9.85%.